BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RED WHITE AND BLUE

    MDR report key: 990607 · Received January 28, 2008

    Report

    Report Number
    3004674232-2008-00001
    Event Type
    Injury
    Date Received
    January 28, 2008
    Date of Event
    December 1, 2007
    Report Date
    December 26, 2007
    Manufacturer
    ALLESEE ORTHODONTIC APPLIANCES (CALEXICO)
    Product Code
    NXC
    PMA / PMN Number
    K040874
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL OF THE DEVICE REVEALED THAT IT WAS DISTORTED, CAUSING THE APPLIANCE TO PROTRUDE AT THE UPPER ANTERIOR GINGIVAL TISSUE. THE PT STOPPED USING THE DEVICE AND IT WAS RETURNED TO THE MFR FOR ADJUSTMENT. THE DOCTOR GAVE THE PT KENALOG ORABASE, A PRESCRIPTION STRENGTH CORTISONE, THAT HE HAD IN HIS OFFICE TO TREAT THE MINOR CUTS. THE PT'S SYMPTOMS COMPLETELY RESOLVED. THE PT IS NOW DOING FINE. EVAL: THE ACTUAL DEVICE INVOLVED IN THIS INCIDENT UNDERWENT VISUAL EVAL. THE RED WHITE AND BLUE APPLIANCE WAS DISTORTED. THIS DISTORTION CAUSED THE APPLIANCE TO PROTRUDE AT THE UPPER ANTERIOR GINGIVAL TISSUE WHICH CAUSED THE IRRITATION TO THE LIP.

    Description of Event or Problem · 1

    THE DOCTOR INFORMED ALLESEE ORTHODONTIC APPLIANCES THAT THE PT'S UPPER LIP WAS SLIGHTLY CUT FROM THE RED WHITE AND BLUE APPLIANCE'S DISTORTED EDGE CUTTING INTO THE PT'S LIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RED WHITE AND BLUE ALIGNER, SEQUENTIAL NXC ALLESEE ORTHODONTIC APPLIANCES (CALEXICO)

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention